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Balancing reproductive responsibility

According to data from the united health foundation, 28.5% of pregnancies are unwanted in the USA.

A team of undergraduate biomedical engineering students from the Ira A. Fulton Schools of Engineering at Arizona State University decided to help reduce that number. They chose to find a new way to balance the responsibility of birth control ownership between genders as a required primary project.

“Female methods tend to be more expensive than current male methods because most require one or more doctor visits, and some methods involve a refillable prescription,” says team captain Candace Pless. “Female birth control has many potential side effects that affect women’s health.”

The team of five students, all of whom graduated after the spring 2022 semester of the School of Biological and Health Systems Engineeringwhich is part of Fulton Schools, received $15,000 VentureWell-sponsored the Venture Prize at the 11th Annual National Institutes of Health Design by Biomedical Undergraduate Teams, or DEBUT, Challenge.

The team was also rewarded in October during the 2022 edition Biomedical Engineering Society Annual meeting in San Antonio, Texas, for winning the Venture Award.

Pless joined Gabriella Estrada and Fatiha Firoz, collaborators on previous group projects, to start the synthesis team. The trio were later joined by classmates Anwar Gandi and Keiry Rodriguez to complete the squad.

Together the group developed a concept called EMIT. It is a minimally invasive male contraceptive using a composite system of injectable hydrogel and chemical deactivator that provides a completely reversible dual barrier to the movement of sperm through the vas deferens, which is the tube that carries sperm during birth. ‘ejaculation.

Why create a new male contraceptive?

There is a market need for a product like this all over the world, especially in the United States.

Pless, who is currently pursuing his MBA at ASU WP Carey School of Businesssays four factors prompted the team to seek a better solution to unplanned pregnancies.

First, the group recognized the current lack of readily available male contraceptives and, second, that biological women generally bear the financial and health burden of contraceptives.

The third factor is the mental burden borne by those who experience unwanted pregnancies due to restrictive legislation that has been passed or is in preparation in several states in the United States. Similar laws exist or are pending in other countries as well.

“[The male contraceptive] could potentially be a new and effective solution to improving someone’s quality of life, no longer having to go through with it,” says Pless. “Additionally, other countries, particularly some in Africa, have high numbers of rape cases and little or no access to contraceptives.”

The final factor that inspired the project is the desire to provide a humane alternative to vasectomies. Having more male contraceptive options available would better balance the responsibility of birth control ownership between biological males and biological females.

“Vasectomy reversal, a surgical procedure that reconnects severed tubes, does not always guarantee restoration of proper function of the vas deferens due to a lack of blood flow to the previously disconnected tissue, which may inhibit its ability to repair itself,” says Pless. . “There is a lot of room for improvement and innovation over current contraceptive methods, especially for couples who prefer more socially and equitable male methods.”

How it works

This final design of the EMIT prototype shows a visual representation of how EMIT would be administered and the results of the reversal when instructed to remove it. Graphic courtesy of Candace Pless

As a new male contraceptive, EMIT is designed to be minimally invasive. The process involves injecting a non-hormonal polymer into the vas deferens to stop sperm motility before ejaculation.

Pless explains that EMIT creates two methods to stop sperm in the vas deferens. It contains a physical barrier made up of natural, biodegradable and non-toxic components that also release microparticles that release an exclusive drug that prevents sperm from moving further. The sperm are then reabsorbed into the body, causing no harm to the patient.

Being a reversible contraceptive, EMIT uses a two-part process consisting of two solutions, called A and B, to reverse the procedure when desired. Part A degrades EMIT and part B flushes EMIT into the vas deferens and urethra.

Developing a male contraceptive requires mentors and experts

The team was initially given a list for their capstone project of about 40 suggested problems for which they could develop a solution, along with the option to choose their own idea. The team came up with their own idea for Jessica Weaverassistant professor of biomedical engineering.

Weaver says she was impressed with the team from the start.

“This is one of the most unique and innovative projects to come in our new biomedical engineering biodevice synthesis track, and it was entirely conceptualized, driven and student-led,” says Weaver. . “It was an honor to be with me on the trip. I can’t wait to see where this will lead as this team works to bring their new venture to market. »

Pless says the project has roughly started. However, she adds that anyone who doubted the success of the project or found it too controversial was shocked when they saw the working prototype in action.

“We definitely blew away all the non-believers,” Pless says.

Early in the project, the team discussed ideas for a new type of male contraceptive with Weaver, quickly realizing that they needed more information about the male reproductive system than was available from the Internet.

Pless contacted the American Urological Association to help you find an expert to answer the team’s questions. They connected with Dr. James SmithProfessor and Director of Male Reproductive Health at University of California, San Franciscowho specializes in minimally invasive vasectomies, microsurgical vasectomy reversal, advanced sperm retrieval techniques, microsurgical varicocele repair, and microsurgical spermatic cord denervation.

“Dr. Smith was able to give us a crash course in the anatomy and physiology of the male reproductive system,” says Pless. “As we learned, we started to narrow our ideas down to what was actually doable. Through Dr. Smith, we caught up with a few of his colleagues to learn more about sperm function.

The second expert the team spoke to was Dr. Russell Hayden, a urologist in Pennsylvania with a subspecialty in male infertility and microsurgery. Hayden helped the team understand vasectomy reversal and how patients view it on how to conceive when a reversal fails.

Pless also contacted Sarah Stabenfeldtassociate professor of biomedical engineering at Fulton Schools with additional positions at ASU School of Life Sciencesto get mentorship on biomaterials and help finding lab space to build their EMIT prototype.

Weaver, Stabenfeldt and Vincent Piziconiassociate professor of biomedical engineering at Fulton Schools, helped the team apply for the DEBUT Challenge.

“Having witnessed the winners of the NIH DEBUT/VentureWell National Design Competition since its inception, it was clear that the EMIT team and its technology were well prepared and ready to compete,” says Pizziconi. “But I never cease to be thrilled that they beat all the top universities in the country for this coveted Venture Award.”

With the knowledge of all their mentors, the team was able to modify EMIT into a viable solution.

The future of EMIT

Pless and Estrada plan to further this technology. They formed a limited liability company together in May, Innovations in MTologyand have filed a patent on their technology.

Currently, the company is working to finalize the second barrier of protection and expand the intellectual property internationally within the next 24 months.

They also intend to participate in other venture capital competitions and the VentureWell E-Team program. Their hope is to get as much mentorship as possible to propel EMIT through the next stages of development and into the market in the future.

“Providing an available male contraceptive is a step towards reproductive justice,” says Pless. “It creates greater equality in family planning and a better balance of responsibilities, both socially and financially.”

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